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Published on: March 15, 2022
Drug-Coated Balloon-Based Strategy for De Novo Coronary Artery Disease Across Complex and High-Risk Indicated
Dong Oh Kang1, Sunwon Kim2, Ae-Young Her3
1Cardiovascular Center, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, South Korea.
Insights
Drug-coated balloon (DCB)-based percutaneous coronary intervention (PCI) shows lower major adverse cardiovascular events (MACE) than drug-eluting stent (DES)-only PCI for de novo coronary artery disease (CAD). This benefit holds across all complex and high-risk indicated PCI (CHIP) risk categories.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- Effectiveness of drug-coated balloon (DCB)-based percutaneous coronary intervention (PCI) for de novo coronary artery disease (CAD) needs further risk stratification.
- Limited data exists for DCB effectiveness in complex and high-risk indicated PCI (CHIP) patients.
Purpose of the Study:
- To compare the efficacy and safety of DCB-based PCI versus DES-only PCI for de novo CAD.
- To evaluate outcomes across different CHIP risk categories.
Main Methods:
- Retrospective analysis of 2022 propensity score-matched patients treated with DCB-based PCI (including DCB-only and hybrid DCB/DES) versus second-generation DES-only PCI.
- Primary endpoint: 2-year incidence of major adverse cardiovascular events (MACE).
- Stratification by CHIP score into low, intermediate, and high-risk groups.
Main Results:
- DCB-based PCI demonstrated consistently lower 2-year MACE rates across all CHIP risk categories compared to DES-only PCI (p < 0.001).
- Significant reduction in target vessel revascularization (TVR) observed in low-to-intermediate risk groups.
- Major bleeding decreased with increasing CHIP risk, particularly in the high-risk group.
Conclusions:
- DCB-based PCI is associated with significantly lower 2-year MACE rates across all CHIP risk strata.
- DCB-based PCI presents a potential alternative to DES-only PCI for selected patients, including those undergoing CHIP PCI.
Background:
Evidence regarding the risk-stratified effectiveness of drug-coated balloon (DCB)-based PCI for de novo coronary artery disease (CAD) remains limited, particularly in patients undergoing complex and high-risk indicated percutaneous coronary intervention (CHIP PCI).
Aims:
To compare the efficacy and safety of DCB-based PCI versus DES-only PCI for de novo CAD across CHIP risk categories.
Methods:
Patients treated with DCB alone or with a hybrid DCB/drug-eluting stent (DES) strategy between 2010 and 2023 were retrospectively analyzed (DCB-based group). The comparator group included patients treated exclusively with second-generation DES from a Korean multicenter registry. The primary endpoint was the 2-year incidence of major adverse cardiovascular events (MACE): cardiac death, myocardial infarction, target vessel revascularization (TVR), target lesion thrombosis, and major bleeding.
Results:
Total 2022 propensity score-matched pairs were stratified by CHIP score into low (0-2; 1660 pairs), intermediate (3-4; 304 pairs), and high (≥ 5; 91 pairs) risk groups. DCB-only treatment accounted for 70.8% of the DCB-based group, with hybrid approaches more frequent in higher-risk patients. Two-year MACE rates increased with CHIP risk in both groups, but remained consistently lower in the DCB-based group: 5.3%, 6.3%, and 20.0% versus 10.9%, 16.9%, and 31.2% for DES-only PCI (log-rank p < 0.001). DCB-based PCI was associated with lower MACE risk across all CHIP categories (all p < 0.05), with no significant interaction (p-interaction = 0.819). TVR reduction was significant in the low-to-intermediate risk (p-interaction = 0.056), and major bleeding declined with increasing CHIP risk, most notably in the high-risk group (p-interaction = 0.044).
Conclusions:
DCB-based PCI was associated with significantly lower 2-year MACE rates across all CHIP risk categories and may offer a potential alternative to DES-only strategies in selective patients. Clinical trial registration number REAL-DCB registry (NCT04619277), PTRG-DES registry (NCT04734028).
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